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Page 1 of 122 SRTR, KI2019_01 Analysis Report Update Appendix 1 Version 1, 6/21/2019 HRSA Contract # HHSH250201500009C COR: Shannon Dunne, JD Analysis Report, Appendix 1: Updated Data Request from the OPTN Kidney Transplantation Committee: Provide KPSAM simulation data on effect of removing DSA and region from kidney/pancreas/kidney-pancreas organ allocation policy Waitlist Mortality Rates, 1-Year Posttransplant Graft Failure Rates, and 1-Year Postransplant Patient Death Rates by Subgroup Prepared By Sally Gustafson, MS, Tim Weaver, MS, Andrew Wey, PhD, Nick Salkowski, PhD, Josh Pyke, PhD, Bryn Thompson, MPH, Katie Audette, MS, Bertram Kasiske, MD, Ajay Israni, MD Data Request ID#: KI2019_01 Timeline Request made: March 28, 2019 Analysis plan due: April 15, 2019 Analysis plan submitted: April 15, 2019 Analysis report due: June 17, 2019 Analysis report submitted: June 14, 2019 Analysis report update submitted: June 21, 2019 Next committee meeting: June 25, 2019 Table of Contents Analysis Report, Appendix 1: Updated ............................................................................................................ 1 Data Request from the OPTN Kidney Transplantation Committee: Provide KPSAM simulation data on effect of removing DSA and region from kidney/pancreas/kidney-pancreas organ allocation policy ................................................................................................................................................................ 1 Waitlist Mortality Rates, 1-Year Posttransplant Graft Failure Rates, and 1-Year Postransplant Patient Death Rates by Subgroup ................................................................................................................ 1 Data Request ID#: KI2019_01 ....................................................................................................................... 1 Executive Summary .................................................................................................................................... 2

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Page 1: Analysis Report, Appendix 1: Updated...Page 1 of 122 SRTR, KI2019_01 Analysis Report Update Appendix 1 Version 1, 6/21/2019 HRSA Contract # HHSH250201500009C COR: Shannon Dunne, JD

Page 1 of 122 SRTR, KI2019_01 Analysis Report Update Appendix 1 Version 1, 6/21/2019

HRSA Contract # HHSH250201500009C COR: Shannon Dunne, JD

Analysis Report, Appendix 1: Updated

Data Request from the OPTN Kidney Transplantation Committee: Provide KPSAM simulation data on effect of removing DSA and region from

kidney/pancreas/kidney-pancreas organ allocation policy

Waitlist Mortality Rates, 1-Year Posttransplant Graft Failure Rates, and 1-Year Postransplant Patient Death Rates by Subgroup

Prepared By

Sally Gustafson, MS, Tim Weaver, MS, Andrew Wey, PhD, Nick Salkowski, PhD, Josh Pyke, PhD, Bryn Thompson, MPH, Katie Audette, MS, Bertram Kasiske, MD, Ajay Israni, MD

Data Request ID#: KI2019_01

Timeline

Request made: March 28, 2019

Analysis plan due: April 15, 2019

Analysis plan submitted: April 15, 2019

Analysis report due: June 17, 2019

Analysis report submitted: June 14, 2019

Analysis report update submitted: June 21, 2019

Next committee meeting: June 25, 2019

Table of Contents

Analysis Report, Appendix 1: Updated ............................................................................................................ 1

Data Request from the OPTN Kidney Transplantation Committee: Provide KPSAM simulation data on effect of removing DSA and region from kidney/pancreas/kidney-pancreas organ allocation policy ................................................................................................................................................................ 1

Waitlist Mortality Rates, 1-Year Posttransplant Graft Failure Rates, and 1-Year Postransplant Patient Death Rates by Subgroup ................................................................................................................ 1

Data Request ID#: KI2019_01 ....................................................................................................................... 1

Executive Summary .................................................................................................................................... 2

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Data Request ................................................................................................................................................... 3

Study population ............................................................................................................................................ 3

Updates to KPSAM .......................................................................................................................................... 3

Metrics assessed ............................................................................................................................................. 3

Analytic approach ........................................................................................................................................... 5

Subgroup Analyses ..................................................................................................................................... 5

Waitlist Mortality ......................................................................................................................................... 6

Posttransplant Mortality .......................................................................................................................... 39

Executive Summary

SRTR used the updated kidney-pancreas simulated allocation model (KPSAM) to assess the simulated impact of eleven allocation frameworks based on nautical miles (NM) between candidate listing program and donor hospital. In interpreting the modeling results it is important to consider that KPSAM cannot model changes in program behaviors under new allocation policies.

All KPSAM runs were performed using a donor-only acceptance model. In contrast to previously published KPSAM runs, which considered both donor and candidate factors as well as donor/candidate interactions, this model only considered donor factors and offer number when predicting the likelihood of offer acceptance.

Update: This report contains all 10 iterations of the requested models.

Description of Runs

Model Number

Model Nickname

Circle Size

Inner Circle Maximum Points

Outer Circle Maximum Points

KI KP/PA

M2 500.500.0.8 500 500 0 8

M3 500.500.4.8 500 500 4 8

M4 500.150.0.8 500 150 0 8

M5 250.250.2.4 250 250 2 4

M6 250.250.0.8 250 250 0 8

M7 250.150.0.8 250 150 0 8

M8 150.150.0.8 150 150 0 8

M9 150.150.0.20 150 150 0 20

M10 500.500.step150 500 500 4 8

M11 500.500.step250 500 500 4 8

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The baseline model (referred to as “BL” in all tables and figures) was the current allocation system, but with local pediatric candidates given priority over candidates with cPRA 98 and 99 for kidneys with KDPI < 35. The committee also wanted to similarly prioritize prior living donors, but prior living donors are not currently modeled by KPSAM.

Models 2-11 are single-circle allocation systems. Proximity points within the circle were assigned linearly, starting at X points for a 0-NM distance between the donor hospital and transplant program, and tapering to 0 points at the circle edge. Likewise, proximity points outside the circle were assigned linearly, starting at Y points at the circle’s edge, and tapering to 0 points at 2500 NM.

Models 10 and 11 also contain a stepwise element, wherein a constant 4 points was awarded between 0-150 NM and 0-250 NM, respectively. This is meant to negate the effect of distance within that area. From there, proximity points taper to 0 at 500 NM. Outside the 500-NM circle, proximity points are assigned as in Models 2, e.g. starting at 8 points at 500 NM and tapering to 0 points at 2500 NM.

Data Request

Using the most recently available KPSAM version and data, model the kidney, pancreas, and kidney-pancreas distribution systems outlined in the KI2019_01 Analysis Plan.

Study population

KPSAM input files were updated to include transplant candidates listed on the kidney, kidney-pancreas, or pancreas transplant waiting lists between January 1, 2017, and December 31, 2017, and donors whose kidneys or pancreata were recovered for transplant in the same time period.

Updates to KPSAM

The unacceptable antigen equivalences and antigen splits used by KPSAM have been updated to match current (September 2018) OPTN policy. In addition, all predictive models used by KPSAM have been updated to incorporate newer data and methodology, including but not limited to the acceptance models and posttransplant outcomes models.

Metrics assessed

As noted in the OPTN data request, SRTR assessed the following outcome metrics for the simulations:

• Count (%) of transplants • Transplant rates • Time on dialysis distribution at transplant, kidney-alone • Time on waiting list distribution at transplant • Organ travel distance (NM) distribution at transplant • Percent of organs traveling over 250 NM • Variance in transplant rates • Variance of median time on dialysis at transplant • Variance in median time on waiting list at transplant

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Relevant DSA-level metrics are shown choropleth maps and provided in an appendix of tables:

• Transplant rates • Median dialysis time at transplant • Median time on waiting list at transplant • Median cPRA at transplant, kidney-alone • Waitlist mortality rates • Change in count of waitlist deaths^

^In tables only

Metrics by organ should also be assessed by the following subgroup populations (including a comparison of percentage of waiting list vs. percentage of transplants where applicable):

• Candidate/recipient age: 0-5, 6-10, 11-17, 18-34, 35-49, 50-64, ≥ 65 years • Candidate/recipient race: white, African American, Asian, other/unknown • Candidate/recipient sex: male vs. female • Candidate/recipient ethnicity: Latino, Not Latino • Candidate/recipient blood type (ABO): A, B, AB, O • Candidate/Recipient cPRA: 0-79, 80-89, 90-94, 95-97, 98, 99, 100 • Candidate/recipient diagnosis: diabetes, hypertension, GN, cystic kidney disease, other • Candidate/recipient time on dialysis: pre-emptive transplant, 0-< 1, 1-< 3, 3-< 5, 5-< 10, ≥ 10

years • SES-related:

– Candidate/recipient insurance status: public vs. private – Median income by recipient zip code at listing/transplant distribution: using the

ACS zip code level publically available dataset – Urbanicity: urban vs. rural, based on RUCA codes (individually, and grouped by

metropolitan vs. micropolitan + small town + rural) • KDPI: 0-20%, 21-34%, 35-85%, 86-100% • EPTS: 0-20%, 21-100% • Donor type: DCD vs DBD • Candidate/recipient sensitization:

– 0-HLA mismatch: 0 vs. non-0 – DR mismatch level: 0, 1, 2

• Geography: – Percentage local (DSA), regional, national – By OPTN Region: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11

Additional figures by subgroup are in this report (Appendix 1):

• Waitlist mortality rate • Post-transplant graft failure rate (1 year) • Post-transplant death rate (1 year)

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The baseline model (referred to as “BL” in all tables and figures) was the current allocation system, but with local pediatrics given priority over cPRA 98 and 99 for kidneys with KDPI < 35.

Models 2 - 9 are single circle allocation systems. Proximity points within the circle were assigned linearly, starting at X points for a 0 NM distance between the donor hospital and transplant center, and tapering to 0 points at the cirlce edge. Likewise, proximity points outside the circle were assigned linearly, starting at Y points at the circle’s edge, and tapering to 0 points at 2500 NM.

Models 10 and 11 are stepwise models, wherein a constant 4 points was awarded between 0 - 150 NM and 0 - 250 NM, respectively. From there, proximity points taper to 0 at 500 NM. Outside of the 500 NM circle, proximity points are assigned as in Models 2-9.

Analytic approach

Each of the eleven requested changes to the allocation system was run with 10 iterations (repetitions) in KPSAM, to provide some measure of variability. Because the same donors and candidates are used in each of the simulations, and they are the actual donors and candidates from 2017 rather than independent samples from a larger population, statistical tests for comparison have no validity. Instead, the average and range of results (minimum - maximum) for the 10 iterations are provided.

Subgroup Analyses

The dot plots below display the range of results across the 10 simulations as a vertical line extending from the minimum value to the maximum value found for that metric and scenario. A point along that line marks the mean value of the metric across the 10 iterations.

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Waitlist Mortality

Waitlist Mortality Rates

Waitlist Mortality Rates: Age 0-17

Waitlist Mortality rates by Age 0-17: Kidney

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Waitlist Mortality Rates: Age 18+

Waitlist Mortality rates by Age 18+: Kidney

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Waitlist Mortality rates by Age 18+: Kidney-Pancreas

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Waitlist Mortality rates by Age 18+: Pancreas

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Waitlist Mortality Rates: Race

Waitlist Mortality rates by Race: Kidney

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Waitlist Mortality rates by Race: Kidney-Pancreas

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Waitlist Mortality rates by Race: Pancreas

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Waitlist Mortality Rates: Ethnicity

Waitlist Mortality rates by Ethnicity: Kidney

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Waitlist Mortality rates by Ethnicity: Kidney-Pancreas

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Waitlist Mortality rates by Ethnicity: Pancreas

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Waitlist Mortality Rates: Sex

Waitlist Mortality rates by Sex: Kidney

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Waitlist Mortality rates by Sex: Kidney-Pancreas

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Waitlist Mortality rates by Sex: Pancreas

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Waitlist Mortality Rates: ABO Group

Waitlist Mortality rates by ABO Group: Kidney

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Waitlist Mortality rates by ABO Group: Kidney-Pancreas

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Waitlist Mortality rates by ABO Group: Pancreas

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Waitlist Mortality Rates: Diagnosis

Waitlist Mortality rates by Diagnosis: Kidney

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Waitlist Mortality rates by Diagnosis: Kidney-Pancreas

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Waitlist Mortality rates by Diagnosis: Pancreas

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Waitlist Mortality Rates: Dialysis Time

Waitlist Mortality rates by Dialysis Time: Kidney

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Waitlist Mortality Rates: cPRA

Waitlist Mortality rates by cPRA: Kidney

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Waitlist Mortality rates by cPRA: Kidney-Pancreas

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Waitlist Mortality rates by cPRA: Pancreas

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Waitlist Mortality Rates: Payment Status

Waitlist Mortality rates by Payment Status: Kidney

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Waitlist Mortality rates by Payment Status: Kidney-Pancreas

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Waitlist Mortality rates by Payment Status: Pancreas

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Waitlist Mortality Rates: Urbanicity

Waitlist Mortality rates by Urbanicity: Kidney

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Waitlist Mortality rates by Urbanicity: Kidney-Pancreas

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Waitlist Mortality rates by Urbanicity: Pancreas

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Waitlist Mortality Rates: EPTS

Waitlist Mortality rates by EPTS: Kidney

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Waitlist Mortality Rates: Median Household Income by Zip Code

Waitlist Mortality rates by Median Household Income by Zip Code: Kidney

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Waitlist Mortality rates by Median Household Income by Zip Code: Kidney-Pancreas

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Waitlist Mortality rates by Median Household Income by Zip Code: Pancreas

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Posttransplant Mortality

Posttransplant Mortality Rates at 1 Year

Posttransplant Mortality Rates at 1 Year: Age at Transplant 0-17

Posttransplant Mortality Rates by Age at Transplant 0-17: Kidney

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Posttransplant Mortality Rates at 1 Year: Age at Transplant 18+

Posttransplant Mortality Rates by Age at Transplant 18+: Kidney

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Posttransplant Mortality Rates by Age at Transplant 18+: Kidney-Pancreas

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Posttransplant Mortality Rates by Age at Transplant 18+: Pancreas

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Posttransplant Mortality Rates at 1 Year: Race

Posttransplant Mortality Rates by Race: Kidney

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Posttransplant Mortality Rates by Race: Kidney-Pancreas

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Posttransplant Mortality Rates by Race: Pancreas

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Posttransplant Mortality Rates at 1 Year: Ethnicity

Posttransplant Mortality Rates by Ethnicity: Kidney

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Posttransplant Mortality Rates by Ethnicity: Kidney-Pancreas

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Posttransplant Mortality Rates by Ethnicity: Pancreas

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Posttransplant Mortality Rates at 1 Year: Sex

Posttransplant Mortality Rates by Sex: Kidney

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Posttransplant Mortality Rates by Sex: Kidney-Pancreas

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Posttransplant Mortality Rates by Sex: Pancreas

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Posttransplant Mortality Rates at 1 Year: ABO Group

Posttransplant Mortality Rates by ABO Group: Kidney

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Posttransplant Mortality Rates by ABO Group: Kidney-Pancreas

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Posttransplant Mortality Rates by ABO Group: Pancreas

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Posttransplant Mortality Rates at 1 Year: Diagnosis

Posttransplant Mortality Rates by Diagnosis: Kidney

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Posttransplant Mortality Rates by Diagnosis: Kidney-Pancreas

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Posttransplant Mortality Rates by Diagnosis: Pancreas

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Posttransplant Mortality Rates at 1 Year: Dialysis Time

Posttransplant Mortality Rates by Dialysis Time: Kidney

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Posttransplant Mortality Rates at 1 Year: cPRA

Posttransplant Mortality Rates by cPRA: Kidney

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Posttransplant Mortality Rates by cPRA: Kidney-Pancreas

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Posttransplant Mortality Rates by cPRA: Pancreas

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Posttransplant Mortality Rates at 1 Year: Payment Status

Posttransplant Mortality Rates by Payment Status: Kidney

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Posttransplant Mortality Rates by Payment Status: Kidney-Pancreas

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Posttransplant Mortality Rates by Payment Status: Pancreas

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Posttransplant Mortality Rates at 1 Year: Urbanicity

Posttransplant Mortality Rates by Urbanicity: Kidney

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Posttransplant Mortality Rates by Urbanicity: Kidney-Pancreas

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Posttransplant Mortality Rates by Urbanicity: Pancreas

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Posttransplant Mortality Rates at 1 Year: Local/Regional/National

Posttransplant Mortality Rates by Local/Regional/National: Kidney

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Posttransplant Mortality Rates by Local/Regional/National: Kidney-Pancreas

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Posttransplant Mortality Rates by Local/Regional/National: Pancreas

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Posttransplant Mortality Rates at 1 Year: Region

Posttransplant Mortality Rates by Region: Kidney

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Posttransplant Mortality Rates by Region: Kidney-Pancreas

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Posttransplant Mortality Rates by Region: Pancreas

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Posttransplant Mortality Rates at 1 Year: EPTS

Posttransplant Mortality Rates by EPTS: Kidney

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Posttransplant Mortality Rates at 1 Year: Median Household Income by Zip Code

Posttransplant Mortality Rates by Median Household Income by Zip Code: Kidney

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Posttransplant Mortality Rates by Median Household Income by Zip Code: Kidney-Pancreas

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Posttransplant Mortality Rates by Median Household Income by Zip Code: Pancreas

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Posttransplant Mortality Rates at 1 Year: Donor KDPI

Posttransplant Mortality Rates by Donor KDPI: Kidney

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Posttransplant Mortality Rates at 1 Year: DCD Donor

Posttransplant Mortality Rates by DCD Donor: Kidney

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Posttransplant Mortality Rates at 1 Year: Number of DR mismatches

Posttransplant Mortality Rates by Number of DR mismatches: Kidney

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Posttransplant Graft Failure Rates at 1 Year

Posttransplant Graft Failure Rates at 1 Year: Age at Transplant 0-17

Posttransplant Graft Failure Rates by Age at Transplant 0-17: Kidney

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Posttransplant Graft Failure Rates at 1 Year: Age at Transplant 18+

Posttransplant Graft Failure Rates by Age at Transplant 18+: Kidney

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Posttransplant Graft Failure Rates by Age at Transplant 18+: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Age at Transplant 18+: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Race

Posttransplant Graft Failure Rates by Race: Kidney

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Posttransplant Graft Failure Rates by Race: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Race: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Ethnicity

Posttransplant Graft Failure Rates by Ethnicity: Kidney

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Posttransplant Graft Failure Rates by Ethnicity: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Ethnicity: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Sex

Posttransplant Graft Failure Rates by Sex: Kidney

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Posttransplant Graft Failure Rates by Sex: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Sex: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: ABO Group

Posttransplant Graft Failure Rates by ABO Group: Kidney

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Posttransplant Graft Failure Rates by ABO Group: Kidney-Pancreas

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Posttransplant Graft Failure Rates by ABO Group: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Diagnosis

Posttransplant Graft Failure Rates by Diagnosis: Kidney

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Posttransplant Graft Failure Rates by Diagnosis: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Diagnosis: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Dialysis Time

Posttransplant Graft Failure Rates by Dialysis Time: Kidney

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Posttransplant Graft Failure Rates at 1 Year: cPRA

Posttransplant Graft Failure Rates by cPRA: Kidney

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Posttransplant Graft Failure Rates by cPRA: Kidney-Pancreas

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Posttransplant Graft Failure Rates by cPRA: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Payment Status

Posttransplant Graft Failure Rates by Payment Status: Kidney

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Posttransplant Graft Failure Rates by Payment Status: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Payment Status: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Urbanicity

Posttransplant Graft Failure Rates by Urbanicity: Kidney

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Posttransplant Graft Failure Rates by Urbanicity: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Urbanicity: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Local/Regional/National

Posttransplant Graft Failure Rates by Local/Regional/National: Kidney

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Posttransplant Graft Failure Rates by Local/Regional/National: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Local/Regional/National: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Region

Posttransplant Graft Failure Rates by Region: Kidney

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Posttransplant Graft Failure Rates by Region: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Region: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: EPTS

Posttransplant Graft Failure Rates by EPTS: Kidney

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Posttransplant Graft Failure Rates at 1 Year: Median Household Income by Zip Code

Posttransplant Graft Failure Rates by Median Household Income by Zip Code: Kidney

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Posttransplant Graft Failure Rates by Median Household Income by Zip Code: Kidney-Pancreas

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Posttransplant Graft Failure Rates by Median Household Income by Zip Code: Pancreas

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Posttransplant Graft Failure Rates at 1 Year: Donor KDPI

Posttransplant Graft Failure Rates by Donor KDPI: Kidney

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Posttransplant Graft Failure Rates at 1 Year: DCD Donor

Posttransplant Graft Failure Rates by DCD Donor: Kidney

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Posttransplant Graft Failure Rates at 1 Year: Number of DR mismatches

Posttransplant Graft Failure Rates by Number of DR mismatches: Kidney